Optimizing a Paraprofessional, Family Partner Navigation Model for Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 312
- 试验地点
- 1
- 主要终点
- Goal Completion
研究概览
简要总结
Family Navigation (FN), an evidence-based care management strategy which is a promising intervention to help low income and minority families access timely mental health services. Despite significant evidence supporting the effectiveness of FN, concerns exist about the ability to disseminate FN to a broad population due to inefficiency and cost. The proposed study employs an innovative research methodology, the Multiphase Optimization STrategy (MOST), a framework for developing highly efficacious, efficient, scalable, and cost-effective interventions. The investigators will conduct a randomized experiment to assess the individual components of FN and identify which components and component levels have greatest effect on access to, and engagement in, diagnostic and treatment services for children with mental health disorders. This information then guides assembly of an optimized FN model that achieves the primary outcomes with least resource consumption and participant burden
详细描述
The goal of this study is to determine the optimal delivery of a Family Navigation (FN) model that increases engagement in services to address children's behavioral health. While there is strong evidence that navigation decreases barriers to care for low income and minority families, little is known about which specific components contribute to its efficacy. The investigators propose to use MOST, a pioneering, engineering-inspired framework, to assess the performance of individual intervention components and their interactions.
Delivery of FN will be systematically varied across four components, each of which is represented by a separate factor in the 2x2x2x2 factorial study design. Specifically, each family will be randomly assigned to one of two conditions within each of four factors or delivery strategies, defining sixteen separate experimental conditions. Strategies include: (A) technology-assisted delivery of care coordination using an innovative, web-based platform called Act.MD (compared to usual care); (B) clinic based FN + community-based (compared to clinic-based only); (C) enhanced symptom tracking using more frequent behavioral symptom tracking (compared to standard pediatric surveillance); and (d) individually-tailored visits (compared to a predetermined schedule of contacts). All children will be followed through the electronic health record (EHR) for 12 months, for outcomes in services access and symptom tracking.
The main effects will be estimated of the four experimental factors and their interactions on the study's primary outcome - family engagement in services to address their child's behavioral health. This information then guides assembly of an optimized FN model that achieves the primary outcomes with least resource consumption and participant burden.
Children will be enrolled if they have a positive behavioral health screen OR parent concern. A "watchful waiting" group for families of children with more mild symptoms and/or who do not choose to access child behavioral services at the time of the index visit with the Family Partner (FP) will be included. These families will be followed and child symptoms tracked at 3, 6, 9 and 12 months. If the watchful waiting children have an increase in symptom severity, and/or the family later desires services, they will have the opportunity to receive FN services and be randomized to a study condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Health Services Research
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All children who are 3-12 years old:
- •who screen positive on the Survey of Wellbeing of Young Children (SWYC) (3-5 years) OR
- •who screen positive on the Pediatric Symptom Checklist-17 (PSC-17) (6-12 years) OR
- •whose parents indicate a behavioral health concern during any pediatric visit
排除标准
- •Children who are already actively engaged in behavioral health specialty care services, defined as having had a behavioral health visit in the last 30 days, who do not require new additional services
- •Children with active psychosis
- •Children with safety concerns requiring emergency mental health services.
研究组 & 干预措施
Group 1- Goat
Clinic-based visit, usual care, standard pediatric surveillance, and structured visits
干预措施: Standard pediatric surveillance (Behavioral)
Group 1- Goat
Clinic-based visit, usual care, standard pediatric surveillance, and structured visits
干预措施: Structured, schedule-based visits (Behavioral)
Group 1- Goat
Clinic-based visit, usual care, standard pediatric surveillance, and structured visits
干预措施: Usual care (Behavioral)
Group 1- Goat
Clinic-based visit, usual care, standard pediatric surveillance, and structured visits
干预措施: Clinic-based visits (Behavioral)
Group 2- Cow
Clinic-based visit, usual care, enhanced pediatric surveillance, and structured visits
干预措施: Usual care (Behavioral)
Group 2- Cow
Clinic-based visit, usual care, enhanced pediatric surveillance, and structured visits
干预措施: Clinic-based visits (Behavioral)
Group 2- Cow
Clinic-based visit, usual care, enhanced pediatric surveillance, and structured visits
干预措施: Structured, schedule-based visits (Behavioral)
Group 10- Bear
Clinic and community visits, usual care coordination, enhanced pediatric surveillance, and structured visits
干预措施: Structured, schedule-based visits (Behavioral)
Group 2- Cow
Clinic-based visit, usual care, enhanced pediatric surveillance, and structured visits
干预措施: Enhanced pediatric surveillance (Behavioral)
Group 3- Horse
Clinic-based visit, technology-enhanced care coordination, standard pediatric surveillance, and structured visits
干预措施: Clinic-based visits (Behavioral)
Group 3- Horse
Clinic-based visit, technology-enhanced care coordination, standard pediatric surveillance, and structured visits
干预措施: Standard pediatric surveillance (Behavioral)
Group 3- Horse
Clinic-based visit, technology-enhanced care coordination, standard pediatric surveillance, and structured visits
干预措施: Structured, schedule-based visits (Behavioral)
Group 3- Horse
Clinic-based visit, technology-enhanced care coordination, standard pediatric surveillance, and structured visits
干预措施: Technology enhanced care coordination (Behavioral)
Group 4- Pig
Clinic-based visit, technology-enhanced care coordination, enhanced pediatric surveillance, and structured visits
干预措施: Clinic-based visits (Behavioral)
Group 4- Pig
Clinic-based visit, technology-enhanced care coordination, enhanced pediatric surveillance, and structured visits
干预措施: Structured, schedule-based visits (Behavioral)
Group 4- Pig
Clinic-based visit, technology-enhanced care coordination, enhanced pediatric surveillance, and structured visits
干预措施: Enhanced pediatric surveillance (Behavioral)
Group 4- Pig
Clinic-based visit, technology-enhanced care coordination, enhanced pediatric surveillance, and structured visits
干预措施: Technology enhanced care coordination (Behavioral)
Group 5- Sheep
Clinic-based visit, usual care, standard pediatric surveillance, and individually-tailored visits
干预措施: Usual care (Behavioral)
Group 5- Sheep
Clinic-based visit, usual care, standard pediatric surveillance, and individually-tailored visits
干预措施: Clinic-based visits (Behavioral)
Group 5- Sheep
Clinic-based visit, usual care, standard pediatric surveillance, and individually-tailored visits
干预措施: Standard pediatric surveillance (Behavioral)
Group 5- Sheep
Clinic-based visit, usual care, standard pediatric surveillance, and individually-tailored visits
干预措施: :Individually-tailored visits (Behavioral)
Group 6- Llama
Clinic-based visit, usual care, enhanced pediatric surveillance, and individually-tailored visits
干预措施: Usual care (Behavioral)
Group 6- Llama
Clinic-based visit, usual care, enhanced pediatric surveillance, and individually-tailored visits
干预措施: Clinic-based visits (Behavioral)
Group 6- Llama
Clinic-based visit, usual care, enhanced pediatric surveillance, and individually-tailored visits
干预措施: Enhanced pediatric surveillance (Behavioral)
Group 6- Llama
Clinic-based visit, usual care, enhanced pediatric surveillance, and individually-tailored visits
干预措施: :Individually-tailored visits (Behavioral)
Group 7- Cat
Clinic-based visit, technology-enhanced care coordination, standard pediatric surveillance, and individually-tailored visits
干预措施: Clinic-based visits (Behavioral)
Group 7- Cat
Clinic-based visit, technology-enhanced care coordination, standard pediatric surveillance, and individually-tailored visits
干预措施: Standard pediatric surveillance (Behavioral)
Group 7- Cat
Clinic-based visit, technology-enhanced care coordination, standard pediatric surveillance, and individually-tailored visits
干预措施: Technology enhanced care coordination (Behavioral)
Group 7- Cat
Clinic-based visit, technology-enhanced care coordination, standard pediatric surveillance, and individually-tailored visits
干预措施: :Individually-tailored visits (Behavioral)
Group 8- Dog
Clinic-based visit, technology-enhanced care coordination, enhanced pediatric surveillance, and individually-tailored visits
干预措施: Clinic-based visits (Behavioral)
Group 8- Dog
Clinic-based visit, technology-enhanced care coordination, enhanced pediatric surveillance, and individually-tailored visits
干预措施: Enhanced pediatric surveillance (Behavioral)
Group 8- Dog
Clinic-based visit, technology-enhanced care coordination, enhanced pediatric surveillance, and individually-tailored visits
干预措施: Technology enhanced care coordination (Behavioral)
Group 8- Dog
Clinic-based visit, technology-enhanced care coordination, enhanced pediatric surveillance, and individually-tailored visits
干预措施: :Individually-tailored visits (Behavioral)
Group 9- Donkey
Clinic and community visits, usual care coordination, standard pediatric surveillance, and structured visits
干预措施: Usual care (Behavioral)
Group 9- Donkey
Clinic and community visits, usual care coordination, standard pediatric surveillance, and structured visits
干预措施: Standard pediatric surveillance (Behavioral)
Group 9- Donkey
Clinic and community visits, usual care coordination, standard pediatric surveillance, and structured visits
干预措施: Structured, schedule-based visits (Behavioral)
Group 9- Donkey
Clinic and community visits, usual care coordination, standard pediatric surveillance, and structured visits
干预措施: Clinic-based visits and community visits (Behavioral)
Group 10- Bear
Clinic and community visits, usual care coordination, enhanced pediatric surveillance, and structured visits
干预措施: Usual care (Behavioral)
Group 10- Bear
Clinic and community visits, usual care coordination, enhanced pediatric surveillance, and structured visits
干预措施: Enhanced pediatric surveillance (Behavioral)
Group 10- Bear
Clinic and community visits, usual care coordination, enhanced pediatric surveillance, and structured visits
干预措施: Clinic-based visits and community visits (Behavioral)
Group 11- Tiger
Clinic and community visits, technology enhanced care coordination, standard pediatric surveillance, and structured visits
干预措施: Standard pediatric surveillance (Behavioral)
Group 11- Tiger
Clinic and community visits, technology enhanced care coordination, standard pediatric surveillance, and structured visits
干预措施: Structured, schedule-based visits (Behavioral)
Group 11- Tiger
Clinic and community visits, technology enhanced care coordination, standard pediatric surveillance, and structured visits
干预措施: Technology enhanced care coordination (Behavioral)
Group 11- Tiger
Clinic and community visits, technology enhanced care coordination, standard pediatric surveillance, and structured visits
干预措施: Clinic-based visits and community visits (Behavioral)
Group 12- Lion
Clinic and community visits, technology enhanced care coordination, enhanced pediatric surveillance, and structured visits
干预措施: Structured, schedule-based visits (Behavioral)
Group 12- Lion
Clinic and community visits, technology enhanced care coordination, enhanced pediatric surveillance, and structured visits
干预措施: Enhanced pediatric surveillance (Behavioral)
Group 12- Lion
Clinic and community visits, technology enhanced care coordination, enhanced pediatric surveillance, and structured visits
干预措施: Technology enhanced care coordination (Behavioral)
Group 12- Lion
Clinic and community visits, technology enhanced care coordination, enhanced pediatric surveillance, and structured visits
干预措施: Clinic-based visits and community visits (Behavioral)
Group 13- Monkey
Clinic and community visits, usual care coordination, standard pediatric surveillance, and individually-tailored visits
干预措施: Usual care (Behavioral)
Group 13- Monkey
Clinic and community visits, usual care coordination, standard pediatric surveillance, and individually-tailored visits
干预措施: Standard pediatric surveillance (Behavioral)
Group 13- Monkey
Clinic and community visits, usual care coordination, standard pediatric surveillance, and individually-tailored visits
干预措施: :Individually-tailored visits (Behavioral)
Group 13- Monkey
Clinic and community visits, usual care coordination, standard pediatric surveillance, and individually-tailored visits
干预措施: Clinic-based visits and community visits (Behavioral)
Group 14- Zebra
Clinic and community visits, usual care coordination, enhanced pediatric surveillance, and individually-tailored visits
干预措施: Usual care (Behavioral)
Group 14- Zebra
Clinic and community visits, usual care coordination, enhanced pediatric surveillance, and individually-tailored visits
干预措施: Enhanced pediatric surveillance (Behavioral)
Group 14- Zebra
Clinic and community visits, usual care coordination, enhanced pediatric surveillance, and individually-tailored visits
干预措施: :Individually-tailored visits (Behavioral)
Group 14- Zebra
Clinic and community visits, usual care coordination, enhanced pediatric surveillance, and individually-tailored visits
干预措施: Clinic-based visits and community visits (Behavioral)
Group 15- Elephant
Clinic and community visits, technology-enhanced care, standard pediatric surveillance, and individually-tailored visits
干预措施: Standard pediatric surveillance (Behavioral)
Group 15- Elephant
Clinic and community visits, technology-enhanced care, standard pediatric surveillance, and individually-tailored visits
干预措施: Technology enhanced care coordination (Behavioral)
Group 15- Elephant
Clinic and community visits, technology-enhanced care, standard pediatric surveillance, and individually-tailored visits
干预措施: :Individually-tailored visits (Behavioral)
Group 15- Elephant
Clinic and community visits, technology-enhanced care, standard pediatric surveillance, and individually-tailored visits
干预措施: Clinic-based visits and community visits (Behavioral)
Group 16- Giraffe
Clinic and community visits, technology-enhanced care, enhanced pediatric surveillance, and individually-tailored visits
干预措施: Enhanced pediatric surveillance (Behavioral)
Group 16- Giraffe
Clinic and community visits, technology-enhanced care, enhanced pediatric surveillance, and individually-tailored visits
干预措施: Technology enhanced care coordination (Behavioral)
Group 16- Giraffe
Clinic and community visits, technology-enhanced care, enhanced pediatric surveillance, and individually-tailored visits
干预措施: :Individually-tailored visits (Behavioral)
Group 16- Giraffe
Clinic and community visits, technology-enhanced care, enhanced pediatric surveillance, and individually-tailored visits
干预措施: Clinic-based visits and community visits (Behavioral)
结局指标
主要结局
Goal Completion
时间窗: 6 months
Successful behavioral health service goal completion obtained from the electronic health record including Family Partner's template documentation.
Time to Goal Completion
时间窗: 18 months
Time to goal completion obtained from the electronic health record including Family Partner's template documentation.
次要结局
- Change in the Survey of Well-being of Young Children (SWYC)(baseline, 6 months)
- Change in Pediatric Symptom Checklist-17 (PSC-17)(baseline, 6 months)
- Change in Family Resource Scale (FRS)(baseline, 6 months)
- Change in the Parental Attitudes Toward Psychological Services Inventory (PATPSI)(baseline, 6 months)
- Change in the Survey of Well-being of Young Children (SWYC)(baseline, 6 months)
- Change in Pediatric Symptom Checklist-17 (PSC-17)(baseline, 6 months)
- Satisfaction With Hospital Care Questionnaire (SHCQ)(6 months)
- Interpersonal Relationship With Navigator (PSN-I)(6 months)
- Change in Family Resource Scale (FRS)(baseline, 6 months)
- Change in Patient Health Questionnaire-2 (PHQ-2)(baseline, 6 months)
- Change in the Parental Attitudes Toward Psychological Services Inventory (PATPSI)(baseline, 6 months)